Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001011178
Ethics application status
Approved
Date submitted
5/07/2019
Date registered
15/07/2019
Date last updated
15/07/2019
Date data sharing statement initially provided
15/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A single centre prospective study on the safety and efficacy of per oral endoscopic myotomy (POEM) in the endoscopic management of achalasia and other oesophageal motility disorder
Scientific title
A single centre prospective study on the safety and efficacy of per oral endoscopic myotomy (POEM) in the endoscopic management of achalasia and other oesophageal motility disorder
Secondary ID [1] 298658 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Achalasia 313553 0
Esophageal Motility Disorder 313554 0
Condition category
Condition code
Oral and Gastrointestinal 311987 311987 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 312058 312058 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The per oral endoscopic myotomy (POEM) procedure involves 4 major steps:
1) Mucosal incision and entry into the submucosal space;
The endoscope enters through the mouth into the oesophagus. A small incision will be made into the oesophagus wall lining, so the endoscope will enter the submucosal space.

2) Creation of submucosal tunnel;
A special knife will be used to tunnel a new pathway within the submucosal layer, to reach the underlying muscle fibres.

3) Myotomy or cutting the circular muscle fibres;
A special knife will be used to partially remove and loosen muscles from the sides of the oesophagus, lower oesophageal sphincter, and upper part of the stomach.

4) Closure of the mucosal defects with clips;
Special endoscopic clips will be used to close of the incision lining of the oesophagus, and the endoscopic tube will be removed by coming back up through the mouth.

The investigator/endoscopist will be administering the POEM procedure. Clinical observation during and after the procedure will be used to monitor fidelity to the intervention (clinical observation and medical notes prior to the procedure will be taken into account).

POEM procedure was first introduced in 2008 for the treatment of achalasia and has become an established endoscopic procedure that utilizes the submucosal space to perform myotomy for the treatment of achalasia.

This procedure requires anaesthesia support with airway intubation, and can be performed in an endoscopy unit. This procedure is similar to other endoscopic procedures and does not require a sterile environment such as in theatre. The procedure will take up to approximately 1 - 1.5 hours to complete.
Intervention code [1] 314921 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320627 0
Degree of success for each participant will be calculated using the Eckardt score following the POEM procedure. It attributes points to 4 symptoms of achalasia (dysphagia, regurgitation, chest pain, and weight loss) and efficacy of the treatment.
Timepoint [1] 320627 0
Eckardt score is assessed within 2 days of the participant's procedure, and is assessed again in 3 months, 6 months, (primary endpoint) 12 months, and 24 months, for their scheduled follow-up GI clinic visits.
Primary outcome [2] 320628 0
Participants will be observed for any procedure-related complications, including bleeding, perforation, and gastroesophageal reflux symptoms. This will be assessed by patient reporting complications they may have experienced, from physical examination and questioning from the investigator at their follow-up clinic visits, or from accessing medical records.
Timepoint [2] 320628 0
This is assessed post-op until the patient is discharged from hospital. Participant will also be assessed for complications for their follow-up GI clinic visits in 3 months, 6 months, (primary endpoint) 12 months, and 24 months.
Primary outcome [3] 320629 0
Patients will be observed for need for readmission, after initial hospital discharge from the POEM procedure. This will be determined using medical records.
Timepoint [3] 320629 0
Participants will be followed up in GI clinic in 3 months, 6 months, (primary endpoint) 12 months, and 24 months. Their medical records will be checked over the 24 month period.
Secondary outcome [1] 372258 0
Total length of hospital stay is measured from the participant's POEM procedure, until their discharge from hospital (i.e. hours / days). This will be assessed by accessing medical records.
Timepoint [1] 372258 0
The duration is assessed immediately after the participant's discharge from hospital.

Eligibility
Key inclusion criteria
American Society of Anaesthesiologists (ASA) III or less.
Confirmed diagnosis of achalasia on high resolution manometry.
Not on anticoagulant or antiplatelet.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
American Society of Anaesthesiologists (ASA) IV
On uninterrupted anticoagulation or antiplatelet medication
Patient with pseudoachalasia from cardiac cancer

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 14142 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 26954 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 303197 0
Hospital
Name [1] 303197 0
Royal Adelaide Hospital
Country [1] 303197 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Port Road, Adelaide, South Australia, 5000
Country
Australia
Secondary sponsor category [1] 303211 0
None
Name [1] 303211 0
Address [1] 303211 0
Country [1] 303211 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303758 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 303758 0
Level 3, Roma Mitchell House, 136 North Terrace, Adelaide, South Australia, 5000
Ethics committee country [1] 303758 0
Australia
Date submitted for ethics approval [1] 303758 0
Approval date [1] 303758 0
20/03/2019
Ethics approval number [1] 303758 0

Summary
Brief summary
The purpose of this study is to assess the safety and efficacy of an endoscopic procedure called “POEM” (Per Oral Endoscopic Myotomy). The POEM procedure is a novel endoscopic treatment used for motility disorders of the oesophagus. POEM is a minimally-invasive endoscopic therapy with similar clinical responses to current surgical treatments, and shown to have shorter recovery time and less post-operative pain.

Who is it for?
You may be eligible for this study if you are 18 years or older and have been diagnosed with the oesophageal motility disorder “Achalasia”.

Study Details
All participants will undergo the POEM procedure; performed with deep sedation administered by an anaesthetist (you are not likely to feel the entire process). The procedure itself involves an endoscope entering through your mouth into the oesophagus, and then a special tiny knife in the endoscope is used to cut away specific muscle fibers in the oesophagus. When this is done the endoscope will come back up through the mouth.
You will be asked to return to the Gastroenterology clinic at 3 months, 6 months, 12 months, and 24 months following your procedure for follow-up visits.

Because POEM has not been formally assessed in South Australia, we are interested to see how well this procedure compares to the current established treatments. We hope this research will help provide information on the safety and usefulness of POEM as a potential replacement for current treatments options for achalasia and other motility disorders of the oesophagus.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94694 0
A/Prof Nam Nguyen
Address 94694 0
Royal Adelaide Hospital, Port Road, Adelaide, South Australia, 5000
Country 94694 0
Australia
Phone 94694 0
+61 8 7074 2189
Fax 94694 0
+61 8 7074 6192
Email 94694 0
[email protected]
Contact person for public queries
Name 94695 0
Mrs Romina Safaeian
Address 94695 0
Royal Adelaide Hospital, Port Road, Adelaide, South Australia, 5000
Country 94695 0
Australia
Phone 94695 0
+61 8 7074 2189
Fax 94695 0
+61 8 7074 6192
Email 94695 0
[email protected]
Contact person for scientific queries
Name 94696 0
Mrs Romina Safaeian
Address 94696 0
Royal Adelaide Hospital, Port Road, Adelaide, South Australia, 5000
Country 94696 0
Australia
Phone 94696 0
+61 8 7074 2189
Fax 94696 0
+61 8 7074 6192
Email 94696 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.